Health product recall

SOMATOM Force, SOMATOM Drive & SOMATOM Confidence-System (2019-11-01)

Starting date:
November 1, 2019
Posting date:
November 29, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-71724



Last updated: 2019-12-02

Affected Products

A. SOMATOM Force

B. SOMATOM Drive

C. SOMATOM Confidence-System

Reason

Sporadic performance problems with the current software versions syngo.CT VA50A (SOMATOM Force) and syngo.CT VA62A(SOMATOM Drive and SOMATOM Confidence) may result in scanning workflow interruptions. Delay in diagnosis or necessity for patient rescan may occur due to this issue.

Affected products

A. SOMATOM Force

Lot or serial number

Not applicable.

Model or catalog number

10742326

Companies
Manufacturer

Siemens Healthcare GMBH

Henkestr. 127

Erlangen

91052

GERMANY


B. SOMATOM Drive

Lot or serial number

Not applicable.

Model or catalog number

10431700

Companies
Manufacturer

Siemens Healthcare GMBH

Henkestr. 127

Erlangen

91052

GERMANY


C. SOMATOM Confidence-System

Lot or serial number

Not applicable.

Model or catalog number

10590100

Companies
Manufacturer

Siemens Healthcare GMBH

Henkestr. 127

Erlangen

91052

GERMANY